Kornimate/medical-research-clean huggingface dataset:
a study to investigate the relative bioavailability and food effect of an oral capsid inhibitor tablet formulation compared with other oral tablet formulations in male and female healthy participants

Conditions: HIV Infections

Summary: this is a 3 part study of an investigational capsid inhibitor, vh4004280, in healthy adult participants. the purpose is to evaluate the effect of tablet formulation as well as food on bioavailability. part 1 of the study will compare the relative bioavailability of vh4004280 formulation a tablets to up to 4 alternative tablet formulations under fed (high fat) conditions. part 2 of the study will assess the effect of fasted conditions on the bioavailability of vh4004280 formulation a and alternative, optional formulations, relative to their respective bioavailability under fed conditions in part 1. the optional part 3 of the study will assess relative bioavailability of vh4004280 formulation a to up to 3 alternative formulations, selected from regimens b, c or d, under fed (lower fat) conditions.


Eligibility criteria:
inclusion criteria: 1. participants must be 18 to 55years of age. 2. participants who are overtly healthy. 3. negative (severe acute respiratory syndrome coronavirus 2) sars-cov-2 test prior to dosing. 4. has body mass index (bmi) within the range 19-32 (kg/m2). 5. participants male at birth must use male condoms, and participants female at birth who are of childbearing potential must be using acceptable forms of birth control. 6. capable of giving signed informed consent. exclusion criteria: 1. history or presence of disorders capable of significantly altering the absorption, metabolism, or elimination of drugs. 2. abnormal blood pressure. 3. any malignancy within the past 5 years except certain localized malignancies, or breast cancer within the past 10 years. 4. has exclusionary psychiatric, hepatic, cardiovascular, gastrointestinal, respiratory, endocrine, neurological, hematological, or renal condition. 5. current or chronic history of liver disease or known hepatic or biliary abnormalities. 6. participants with exclusionary electrocardiogram findings. 7. past or intended use of exclusionary medications or vaccines. 8. exposure \> 4 new investigational products within 12 months, previous participation in this study, or current enrolment or participation in another investigational study. 9. alt \>1.5x upper limit of normal (uln), total bilirubin \>1.5x uln, and/or estimated serum creatinine clearance \<60 ml/min. 10. history of or current infection with hepatitis b or hepatitis c. 11. positive sars-cov-2 test, having signs and symptoms suggestive of covid-19, or contact with known covid-19 positive person. 12. positive hiv antibody test. 13. participants with positive results for illicit drug use, regular use of drugs of abuse, tobacco or nicotine-containing product use, and/or excessive alcohol use.

Keywords: human immunodeficiency virus hiv-1 capsid inhibitor vh4004280 food effect fasted conditions fed conditions bioavailability
the study of differences in eosinophil function and subsets in patients with eosinophilic pulmonary diseases

Conditions: Eosinophil Subtype; Eosinophilic Pulmonary Diseases

Summary: the study subjects of this research are patients with eosinophil-associated pulmonary diseases, including eosinophilic granulomatosis with polyangiitis, idiopathic hypereosinophilic syndrome, idiopathic acute eosinophilic pneumonia, idiopathic chronic eosinophilic pneumonia, and primary simple pulmonary eosinophilia. the aim is to detect eosinophil subtypes in peripheral blood based on surface protein expression, to understand the differences in eosinophil subtypes among patients with different diseases, to elucidate the significance of different eosinophil subtypes, and ultimately to provide a theoretical basis for the selection of treatment directions for patients.


Eligibility criteria:
inclusion criteria: * for healthy volunteers: healthy volunteers matching the age and gender of the study subjects * for epd: ① persistent eosinophil count increase\>1500 per cubic millimeter for more than 6 months. ② lack of evidence of a secondary cause of eosinophilia is required. ③ signs and symptoms of end-organ damage presumed to be secondary to eosinophilia exclusion criteria: * patients with concurrent definitive pulmonary infections, malignancies, or other parenchymal lung diseases; * patients who are unable or unwilling to cooperate with the collection of clinical information (e.g., due to mental disorders, memory impairments, etc.); * patients who are unable to provide informed consent.
mannitol versus hypertonic saline solution in the treatment of elevated intracranial pressure

Conditions: Intracranial Hypertension

Summary: the purpose of this study is to determine whether mannitol is as effective as hypertonic saline solution in the treatment of elevated intracranial pressure in patients with brain injury.

elevation of intracranial pressure (icp) to more than 20 mmhg plays a major role in the worsening of the neurological status through the impairment of brain perfusion. in an effort to reduce the intensity and the time spent with increased icp, infusion of mannitol has been the recommended first-line agent for years. the growing interest in the use of hypertonic saline solutions (hss) in this clinical setting has, however, challenged the use of mannitol. because mannitol and hss may differ regarding their clinically relevant mechanisms of action, there is a need to determine which osmotic compound could be the most appropriate in patients with elevated icp. we conduct thus a parallel, randomized controlled trial comparing the effects of an equimolar infusion of 20% mannitol or 7.45% hss without colloid in patients with elevated icp. the primary end point of this trial is the magnitude of icp and of cerebral perfusion pressure (cpp) changes following treatment during a study period of 120 min.

Eligibility criteria:
inclusion criteria: * age 18 or older * sustained elevated intracranial pressure to more than 20 mmhg for more than 10 min * mechanically ventilated in stable conditions for more than 2 hours prior to the study * serum osmolality ranged between 280 and 320 mosm/kg exclusion criteria: * imminent cranial or extracranial surgery * leakage or drainage of cerebral spinal fluid * unstable respiratory and hemodynamic conditions * oliguric renal failure * anemia * use of mannitol or hss in the previous 6 hours * concomitant use of thiopentone

Keywords: intracranial pressure mannitol hypertonic saline solution brain injury traumatic brain injury adult patients with elevation of intracranial pressure (icp > 20 mmhg)
efficacy, safety, pharmacokinetics and pharmacodynamics of icp-488 in patients with moderate to severe plaque psoriasis

Conditions: Moderate to Severe Plaque Psoriasis

Summary: this is a multicenter, randomized, double-blind, placebo-controlled phase ii clinical study to evaluate icp-488.efficacy, safety, pk, and pd characteristics in chinese adults with moderate to severe plaque psoriasis.


Eligibility criteria:
inclusion criteria: 1. subjects voluntarily participate in this study and have signed informed consent. 2. male or female subjects between the ages of 18 and 70 (including the threshold) at the time of signing the icf. 3. history of plaque psoriasis ≥6 months at baseline. 4. subjects need to receive systemic therapy and/or phototherapy. 5. the following three criteria were met: a) psoriasis area and severity index (pasi) score ≥12; b) psoriasis affected body surface area (bsa) ≥10%; c) static physician overall assessment (spga) ≥3 scores exclusion criteria: 1. the diagnosis was non-plaque psoriasis. 2. presence of infection or immune-related disease. 3. subjects with a history of tb or at risk for tb. 4. received related treatment within the time window specified in the protocol. 5. an interval of less than 5 half-lives or 28 days (if any available halflife data) from the last dose of a strong cyp1a2 inhibitor or inducer, or a plan to use concurrently medications, dietary supplements or food with strong cyp1a2 inhibitory or inductive effect during study participation. 6. the investigator has determined that there are clinically significant test results and that participation in this trial would pose an unacceptable risk to patients; or the laboratory values of the subjects in the screening period meet the criteria specified in the protocol. 7. pregnant or lactating women, or women who plan to become pregnant during study participation. 8. a history of severe drug allergies. 9. any other conditions in which the investigator considers it unsuitable for the subject to participate in this study.
pediatric in-hospital cardiac arrest international registry (pachin)

Conditions: Cardiac Arrest; Pediatric ALL; In-hospital Cardiac Arrest

Summary: : an intrahospital ca data recording protocol has been designed following the utstein model. database is hosted according to european legislation regarding patient data protection. it is drafted in english and spanish. invitation to participate has been sent to spanish, european and latinamerican hospitals. variables included, asses hospital characteristics, the resuscitation team, patient's demographics and background, cpr, post-resuscitation care, mortality, survival and long-term evolution. survival at hospital discharge will be evaluated as a primary outcome and survival with good neurological status as a secondary outcome, analyzing the different factors involved in them

study design: this study is a multicenter, international, prospective observational registry. setting: patients will be enrolled by participating investigators from european and latinamerican countries. all sites are susceptible of treating pediatric cardiac arrest patients. participating hospitals differ in levels of care but are all able to submit their data to the study's database. patient elegibility: inclusion criteria: all children aged 1 month to 18 years who suffer a ca in hospital. for the study, ca is defined as the absence of vital signs requiring at least one minute of chest compressions. subsequent episodes of ca may be included for the same individual. exclusion criteria: patients being treated with extracorporeal circulatory support (ecmo or ventricular assistance) at the time of ca. patients who suffer a cardiac arrest and require ecmo for rosc, after performing conventional cpr, will not be excluded. duration of the data collection period 24 months. recruitment: study candidates will be identified by a study physician, who will explain the study to parents or guardians. written informed consent will be obtained from parents or guardians prior to inclusion in the study. a consort (consolidated standard of reporting trials) flow diagram is shown in figure 1. data collection: data will be collected, verified, and uploaded to a protected electronic web-based database (xolomon) by their designated site coordinators/investigators under the oversight of their irb. database has been designed following the utstein model (19). database is hosted according to european legislation regarding patient data protection. it is drafted in english and spanish.

Eligibility criteria:
inclusion criteria: * all children aged 1 month to 18 years who suffer a ca in hospital exclusion criteria: * patients being treated with extracorporeal circulatory support (ecmo or ventricular assistance) at the time of ca. * duration of resuscitation \< 1minute

Keywords: pediatric cardiac arrest outcomes survival cardiopulmonary resuscitation
relationship between lymph node ratio and survival rate in preoperative chemoradiation rectal cancer patients

Conditions: Rectal Cancer

Summary: colorectal cancer is the most-common cancer of the gastrointestinal tract. the number of positive lymph nodes and total number of lymph nodes retrieved are important prognostic factors. in patients who do not receive preoperative chemoradiation, the total number of lymph nodes should be more than 12 nodes to predict accurate staging. in cases of locally-advanced rectal cancer when patients receive neoadjuvant chemoradiation it is sometimes impossible to retrieve adequate amount of lymph nodes due to the chemoradiation effect. therefore, this study was to evaluate and predict survival rates based on positive lymph node ratio.

the primary endpoint of this study was to assess the lymph node ratio as another predictor for survival rate in preoperative chemoradiation rectal cancer patients. the other secondary objective was to determine the relationship between total harvested lymph nodes and survival rate in each stage. this is a retrospective, single-centered study, collecting data of patients from january 2011 to december 2017. including a total of 163 patients with rectal cancer who underwent surgery following neoadjuvant chemoradiation. using cox regression and kaplan-meier survival analysis to determine whether the lymph node ratio can be used to predict the survival rate and determine the cut-off value to distinguish the prognosis of the disease.

Eligibility criteria:
inclusion criteria: * patients with rectal cancer who underwent surgery following neoadjuvant chemoradiation. * patients have tissues confirmed by pathology * no metastasis before surgery exclusion criteria: * distant metastasis during surgery

Keywords: rectal cancer lymph node after neoadjuvant rectal cancer
influence of opioids on circulating tumor cells in radical cystectomy

Conditions: Bladder Cancer

Summary: multiple lines of evidence have shown that perioperative opioids requirement was associated with poor outcomes in cancer patients, including increased cancer progression and metastases and reduced survival in patients with lung, breast, prostate, and bladder cancer. circulating tumor cells (ctcs) have been validated as prognostic biomarkers of a number of cancers. the aim of this study is to investigate the effects of perioperative opioids on the number of ctcs in patients receiving robot-assisted laparoscopic radical cystectomy. the difference of the amounts of perioperative opioids is achieved by using general anesthesia combined with intravenous opioid-based analgesia intra- and post-operatively in one group and general analgesia combined with epidural ropivacaine-based analgesia in the other group.


Eligibility criteria:
inclusion criteria: * age \>=18 * asa i-ii * patients with primary bladder cancer of stage t2a or higher, who are scheduled for robot-assisted laparoscopic radical cystectomy * written informed consent exclusion criteria: * emergency surgery * palliative surgery * contraindications for epidural anesthesia * metastatic bladder cancer * patients with a history of any other malignancy * chronic opioids medication * severe systemic disease (heart, lung, kidney, or immune system) * known hypersensitivity or suspected allergy to intervention drugs * intellectual disability

Keywords: circulating tumor cells opioid epidural anesthesia radical cystectomy
safety and efficacy of using master to perform endoscopic submucosal dissection in human

Conditions: Gastric Cancer; Colon Cancer

Summary: this trial is to evaluate the safety and efficacy of using master, a robotics enhanced endosurgical system to perform endoscopic submucosal dissection (esd) of gastric/colon cancer in human.

this trial is to evaluate the safety and efficacy of using master, a novel robotics enhanced endosurgical system to perform endoscopic submucosal dissection (esd) of gastric/colon cancer in human. the master is a master-and-slave robotic system that is deployed through a standard dual-channel therapeutic endoscope. it introduces robotic control of endoscopic surgical tools and tasks through an ergonomic human-machine interface built around the original endoscopic paradigm. in doing so, it separates control of instrumental motion from that of endoscopic movement such that surgical tasks may be independently executed by a second operator via a human-machine interface. with it, endoscopically deployed instruments can be independently controlled, allowing thus bimanual coordination of effector instruments to facilitate actions such as retraction/exposure, traction/countertraction, approximation and dissection of tissue. using the master, operational dexterity is increased, thus making it easier for the operator to perform the esd procedure as compared with using the conventional endoscope. this study will measure the ease of using the master to perform the various surgical tasks involved in the esd procedure, the time taken to perform the procedure, and record complications, if any, occurred during and after the procedure.

Eligibility criteria:
inclusion criteria: * patient diagnosed with early gastric or colon cancer, is deemed suitable to undergo endoscopic submucosal dissection and is able/willing to give informed consent. exclusion criteria: * case is deemed not suitable for endoscopic submucosal dissection * is on warfarin or other blood thinning agents and those with bleeding disorders * has uncorrected coagulopathy or severe thrombocytopenia precluding biopsy * has serious co-morbidities such as heart disease, renal impairment and cancer * has recently underwent surgery or has a personal history of stomach/colon cancer or surgery * is unable/unwilling to give informed consent * is pregnant or breast-feeding women patients who cannot undergo gastroscopies

Keywords: gastric cancer colon cancer endoscopic submucosal dissection
trial of psychoeducational and hypnosis interventions on the fatigue associated with pbc in women

Conditions: Liver Cirrhosis, Biliary

Summary: fatigue is a clinical symptom that has been described as the most disturbing by around 50% of patients with pbc. it has an important impact on patients' quality of life and is associated with an increased mortality risk. to treat fatigue in pbc, only medical treatments have been tested with limited efficacy or serious sides' effects. in other diseases, mostly cancer, psychological interventions showed efficacy on fatigue decrease. most interventions consist in psychoeducation with: education about fatigue, development of self-care or coping techniques, activity management and learning to balance between activities and rest. hypnosis, which consists in a body work for psycho-therapeutic use (e.g., through imagination), has also shown promising results. moreover, psychological intervention efficacy seems to be influenced by patients' characteristics, such as personality. therefore, the first aim of the present single-center randomized controlled phase 2 trial is to assess the efficacy of a psycho educational intervention and a hypnosis intervention on pbc patients' fatigue to demonstrate that both psychoeducational and hypnosis interventions decrease patient fatigue.


Eligibility criteria:
inclusion criteria: * women from 18 to 75 years old, * diagnosis of primary biliary cholangitis (pbc) according to recognized criteria (easl 2017), * medically stable under treatment with udca initiated for at least 6 months, ie medically stable on the basis of liver biological parameters (no increase of more than 20% in bilirubin, alp and transaminases) and absence of disabling pruritus (permanent and eva\> 6/10 or scratching lesions), * presenting a significant level of fatigue (fatigue score on pbc-40\>= 33), * understanding the french language, * availability and ability of the patient to access an internet network terminal to answer the online questionnaires of the study, * signed consent form. exclusion criteria: * presence of cirrhosis with a child-pugh b or c, * presence of disabling pruritus (permanent, or eva\>= 7/10 in the last 3 weeks, or objectivable scratching skin lesions), * patient on liver transplantation waiting list or total bilirubin\> 50 μmol / l (3 mg / dl), or recent complication (\<6 months) of cirrhosis (ascites, hepatic encephalopathy, rupture bleeding) of esophageal varices), * untreated depressive disorder, * any comorbidity not medically controlled (i.e. all dosage changes \<3 months due to a control of the associated pathology deemed insufficient by the referring physician) or life-threatening in the medium term (within 2 years). * psychiatric disorder modifying the relationship to the reality

Keywords: liver cirrhosis, biliary female cholangitis hypnosis psychological treatment
1:1 comparison of the pocket colposcope in kenya

Conditions: Cervical Cancer; HPV Infection; HIV Infections

Summary: the pocket colposcope has 510k fda clearance and has been successfully used in almost 1500 unique patients globally in duke and non-duke protocols to date. 400 women who are hpv-positive and planned to undergo treatment at 6 ministry of health-supported outpatient clinics in kisumu county will be recruited to the study. after providing informed consent, participants will be randomized 1:1 to either standard-of-care visual inspection or colposcopy with the pocket colposcope

women randomized to the standard-of-care arm will undergo via followed by visual inspection with lugol's iodine (vili). women randomized to the pocket colposcope arm will undergo pocket-assisted via (pa-via), green light imaging, and vili using the pocket colposcope. women in both arms will have biopsies taken of any suspicious lesions, or two biopsies taken in random locations if no lesions are visible. the locations of the biopsies will be based on provider impression. after their study-exams and biopsies are taken, women who are eligible for ablative treatment will be immediately treated in the clinic. those with larger lesions or lesions concerning for invasive cancer will be referred to the local hospital for an excisional procedure.

Eligibility criteria:
inclusion criteria: 1. age \> 25 years old and \< 65 years old 2. sex: female 3. positive hpv test within past 6 months 4. hiv+ women exclusion criteria: 1. pregnant women (cannot perform a cervical biopsy on a patient who is pregnant unless absolutely indicated) 2. women with a negative hpv test 3. patients incapable of giving informed consent 4. women with a history of cervical cancer 5. pelvic exam concerning for cervical cancer or cervical infection

Keywords: cervical cancer screening, pap smear, colposcopy pap smear colposcopy